Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12613000400763
Ethics application status
Approved
Date submitted
9/04/2013
Date registered
12/04/2013
Date last updated
31/07/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
A study to compare the capsule formulation of BIT225 to the original powder formulation in healthy participants.
Query!
Scientific title
A Phase I, Open-Label, Randomised, Single Dose, Crossover Pharmacokinetic Study Comparing a Capsule Formulation of BIT225 to the Current Oral Suspension Administered in Healthy Participants.
Query!
Secondary ID [1]
282249
0
BIT225-007
Query!
Universal Trial Number (UTN)
U1111-1141-4972
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hepatits C Virus
288776
0
Query!
Condition category
Condition code
Infection
289128
289128
0
0
Query!
Other infectious diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
BIT225 powder 400mg, single dose, oral administration
or
BIT225 4 x 100mg capsules, single dose, oral administration
followed by the alternate dose form 10-14 days later.
Dosing will supervised within a Phase I unit.
The concentration of drug in the blood will be measured using a validated assay as described in the primary outcome.
Query!
Intervention code [1]
286866
0
Treatment: Drugs
Query!
Comparator / control treatment
The original powder formulation is the control.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
289241
0
To compare the pharmacokinetic characteristics of a single dosage of BIT225 suspension (400 mg) and capsule formulation (4 x 100 mg) in healthy participants.
The concentration of BIT225 in the blood will be measured using a validated liquid chromatography/ mass spectrometry method.
Pharmacokinetic parameters such as the area under the concentration (AUC) versus time curve, maximum concentration (Cmax), time to maximum concentration (Tmax), half life, clearance will be used to assess the primary outcome.
Query!
Assessment method [1]
289241
0
Query!
Timepoint [1]
289241
0
96 hours
Query!
Secondary outcome [1]
302092
0
To compare the tolerability of BIT225 400 mg in suspension compared to 4 x 100 mg BIT225 capsule formulation following a single dosage in healthy participants.
Tolerability will be assessed by comparison of treatment emergent adverse events, changes in vital signs, ECG parameters, and routine laboratory tests.
Query!
Assessment method [1]
302092
0
Query!
Timepoint [1]
302092
0
up to 14 days post dose
Query!
Eligibility
Key inclusion criteria
1. Be male or female (of non-child bearing potential), aged between 18 and 49 years (inclusive).
2. Healthy participants – defined as participants who are free from clinically significant illness or disease as determined by their medical history, physical examination, 12- lead ECG (QTc less than 450 ms) and clinical laboratory determinations.
3. Normotensive (systolic BP less than 140 mm Hg and diastolic BP less than 90 mm Hg).
4. Body Mass Index (BMI) btween 19 and 29 kg/m2.
5. Weight between 55 kg and 110kg.
6. Participants who smoke less than one cigarette or tobacco form (including cigars) per month in the last 12 months.
7. Adequate venous access in the left or right arm to allow collection of a number of blood samples.
8. Fluent in the English language.
9. Provide written informed consent to participate in the study and be willing to comply with the study procedures.
10. No abnormal finding of clinical relevance at the screening evaluation.
11. Agree to use a combination of two approved methods of contraception, from screening and until 30 days after administration of the study drug.
12. Females must have a negative pregnancy test at Screening (baseline) and Day -1.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
49
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
1. Currently taking or have taken antiretroviral therapy in the last 30 days.
2. Any condition that would interfere with drug absorption (e.g. chronic diarrhoea).
3. A history of pancreatitis or hepatitis within the previous 3 years.
4. Abnormal laboratory test results, deemed clinically significant by the Medical Officer (Principal Investigator or medically qualified nominee), within 21 days before enrolment, including anaemia (haemoglobin less than 11.0 g/dl for men and 10.0 g/dl for women), neutropenia, thrombocytopenia and elevated liver function test results more than two times the upper limit of normal. Renal function impairment (Creatinine clearance less than 50mL/min).
5. Unable to withhold concomitant medication for 48 hours prior to dosing and for the duration of confinement.
6. As a result of medical review, physical examination or screening investigations, the Medical Officer considers the participant unfit for the study.
7. Positive urine drug test or alcohol breath test at screening.
8. Use of macrolide antibiotics (eg. Erythromycin), azole antifungal agents (eg. Ketoconazole) within 30 days of study dosing.
9. Evidence of clinically relevant oral, cardiovascular, haematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder.
10. History of epilepsy.
11. History of coronary diseases, peripheral vascular diseases, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease.
12. Acute therapy for a serious infection within 30 days of study entry.
13. Positive screening test for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody and HIV.
14. Have participated in a clinical trial or receipt of an experimental therapy within 60 days prior to dosing.
15. Blood donation of greater than 550 mL within 90 days before the first dose administration.
16. Consumption of grapefruit or grapefruit juice within 14 days prior to the first day of study confinement and through to completion of the confinement period.
17. Those who regularly drink more than four (4) units of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit) or those who may have difficulty abstaining from alcohol during the 36 hours prior to dose administration and until completion of blood sampling.
18. Unwilling or unable to fast for the 10 hours prior to dosing.
19. Women of child bearing potential, pregnant or breast feeding women.
20. Male partners of pregnant females.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by placing all 14 randomisation numbers in a box. The first 7 numbers withdrawn were allocated to receive the powder formulation in the first cycle.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Pharmacokinetics
Query!
Statistical methods / analysis
Descriptive statistics such as mean, standard deviation and coefficient of variation for all pharmacokinetic parameters will be calculated.
The number of participants was based on the FDA Guidance for Industry, Bioavailability and Bioequivalence Studies for Orally Administered Drug Products (2003).
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
11/04/2013
Query!
Actual
11/04/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
11/04/2013
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
14
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
WA
Query!
Recruitment postcode(s) [1]
6656
0
6009 - Nedlands
Query!
Funding & Sponsors
Funding source category [1]
287015
0
Commercial sector/Industry
Query!
Name [1]
287015
0
Biotron Limited
Query!
Address [1]
287015
0
Suite 1.9, 56 Delhi Rd
North Ryde NSW 2113
Query!
Country [1]
287015
0
Australia
Query!
Primary sponsor type
Commercial sector/Industry
Query!
Name
Biotron Limited
Query!
Address
Suite 1.9, 56 Delhi Rd
North Ryde NSW 2113
Query!
Country
Australia
Query!
Secondary sponsor category [1]
285798
0
None
Query!
Name [1]
285798
0
Query!
Address [1]
285798
0
Query!
Country [1]
285798
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
289055
0
Bellberry Limited
Query!
Ethics committee address [1]
289055
0
229 Greenhill Road
Dulwich
South Australia 5065
Query!
Ethics committee country [1]
289055
0
Australia
Query!
Date submitted for ethics approval [1]
289055
0
Query!
Approval date [1]
289055
0
26/03/2013
Query!
Ethics approval number [1]
289055
0
Query!
Summary
Brief summary
BIT225 powder has been used in several trials to date to investigate safety and effectiveness. A capsule formulation, being a more acceptable dose form than the powder, has been developed for use in future trials and as a possible future marketed formulation. This trial is to compare a single dose of the capsule to a single dose of the powder to see how much of the drug gets into the bloodstream and how long does the body take to remove it, what is the maximum concentration of the drug in the bloodstream after a single dose, and how well the capsule is tolerated compared to the powder form.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
39006
0
Dr Janakan Krishnarajah
Query!
Address
39006
0
Linear Clinical Research Limited
1st Floor, B Block,
Hospital Avenue,
Nedlands WA 6009
Query!
Country
39006
0
Australia
Query!
Phone
39006
0
+61 8 6382 5100
Query!
Fax
39006
0
+61 8 9381 4453
Query!
Email
39006
0
[email protected]
Query!
Contact person for public queries
Name
39007
0
Dr Michelle Miller
Query!
Address
39007
0
Biotron Limited
Suite 1.9, 56 Delhi Rd
North Ryde NSW 2113
Query!
Country
39007
0
Australia
Query!
Phone
39007
0
+61 2 9805 0488
Query!
Fax
39007
0
+61 2 9805 0688
Query!
Email
39007
0
[email protected]
Query!
Contact person for scientific queries
Name
39008
0
Dr Michelle Miller
Query!
Address
39008
0
Biotron Limited
Suite 1.9, 56 Delhi Rd
North Ryde NSW 2113
Query!
Country
39008
0
Australia
Query!
Phone
39008
0
+61 2 9805 0488
Query!
Fax
39008
0
+61 2 9805 0688
Query!
Email
39008
0
[email protected]
Query!
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF